1. Field of the Invention
The present invention relates generally to compositions and their use as dietary nutritional supplements. More specifically, the present invention relates to nutritional dietary formulations of fermented soybean product in combination with selected herbs and spices.
2. Description of the Prior Art
By way of background, the literature is replete with references to health benefits of herbs, spices, and natural food products. Approximately 75% of FDA approved drugs from 1981-2002 were either natural products, were based on natural products, or mimicked them in one form or another. Approximately 25% of the drug prescriptions in the United States are compounds derived from plants that were discovered through scientific investigation of folklore claims (Reynold, T. J., Natl. Cancer Inst. 183: 594-596, 1991). A significant percentage of our current pharmaceuticals were obtained from isolation of natural products involved in longstanding traditional or folklore remedies.
Soy. In the treatment of cancer and other diseases, patients frequently exhibit symptoms that interfere with their recovery even when there is clinical remission of disease. For example, malnutrition, anexoria, and cachexia are common problems with cancer patients. Cachexia occurs in more than 80% of patients who have advanced cancer with symptoms of loss of appetite, chronic nausea, fatigue, and changes in body weight, lean body mass, and total body fat (Bruera E 1998). Anorexia is associated with prolonged hospital stay and length of stay for rehabilitation. (Guo Y 2005). There are few effective treatments for the problem of cancer-associated cachexia. New treatment regimes to treat anorexia and cachexia in patients with advanced cancer are urgently needed. Soy isoflavones its metabolites have been shown in clinical, laboratory and epidemiological studies to be effective nutritional adjuvants for patients diagnosed with cancers.
Whole soybeans contain about 40% protein and are naturally high in isoflavones (including genistein, daidzein and their metabolites), phytosterols, saponins, protease inhibitors, phytic acid compounds, and the branched-chain fatty acid 13-methyl-tetradecanoic acid, that have been associated with positive nutritional effects, including reduction of blood serum cholesterol levels among other health benefits. The active agent MDT-13 (13-methyl-tetradecanoic acid) has been shown to induce apoptosis in tumor cell (Yang, Z., et al., 2000).
Fermented soy products are known to offer a broader nutrient profile than non-fermented soy foods such as soy milk soy nuts, tofu, and fresh or dry soybeans. The fermentation process increases the bioavailability of the constituents in soy by removing trypsin inhibitors found on the coating of soy that interfere with the absorption of nutritive compounds. The benefits of fermented soy include reducing risks of certain types of cancers, promoting heart and bone health, and alleviating menopausal symptoms. Fermented soy methods and products are described in U.S. Pat. Nos. 4,877,739 and 7,070,965.
Herbs and Spices. Although spices are generally added to food to improve taste, besides adding to taste they have a variety of functions that include providing antimicrobial activity, antioxidant functions, and a wide range of medicinal benefits. For example, in traditional folk medicine various herbs and spices have been used to treat digestive problems, including aiding digestion; relieving intestinal gas, constipation, diarrhea, dysentery; and even eliminating worms from the intestinal tract. While some medical claims for the efficacy of natural products have undoubtedly been exaggerated and others have proven false, many important medical claims have been confirmed and others are currently being investigated.
The variety of active compounds found in herbs and spices (i.e., phthallides, polyacetylenes, phenolic acids, flavonoids, coumarins, capsicinoids, triterpenoids, sterols, monoterpenes, alkaloids, etc) likely account for their activity. For example, antibacterial activity from dietary spices and medicinal herbs has been closely associated with their phenolic constitutents [Shan, B., et al., International J. Food Microbiol, 117(1):112-119 (2007)], Herbs and spices linked to digestive and other health benefits include, caraway and mustard seeds, juniper berries, spearmint, cinnamon, mace, pepper, ginger, coriander, fennel, cumin, nutmeg, sage, chocolate, garlic, dill, hyssop, oregano, rosemary, bee balm, lemon balm, sage, savory, thyme, parsley, bilberry, St. John's Wort, milk thistle, green tea, purslane, grape seed, cardamon, ginko, King Solomon's Seal, clove, stevioside, peppermint, licorice, sassafras, and turmeric. Cinnamon, for example, predominantly grown in India, China and Sri Lanka, might provide a natural remedy against adult onset type II diabetes, lowering “bad” LDL cholesterol, anti-blood clotting action, boosting brain function and alertness, treating colds and flu, and acting as a mild stimulant [Hunter, B., Consumers Res. Mag., 85(10):8-8 (2002); Grey, L. W., Better Nutrition, 69:18 (2007)]. Curcumin, the ingredient of turmeric that provides its yellow color, has shown promise treating Alzheimer's disease, cancer (i.e., ongoing research at M.D. Anderson Cancer Center in Houston, Tex.), and cystic fibrosis [Consumer Reports, 71(1):49 (2006]. Ginger has a long history of medicinal use dating back over 2500 years is reported to help with motion sickness, loss of appetite, nausea, and to have anticancer properties attributed to certain vanilloids as well as other constituents like shogaols and zingerone [Shukla, Y., et al., Food Chem. Toxicol, 45:(5):683-690 (2007)]. Raw ginger is reported to have hypoglycaemic, hypocholesterolaemic and hypolipidaemic potential and may be of great value in managing diabetic complications [Al-Amin, Z. M., et al., Br. J. Nutr., 96(4):660-666 (2006)]. [6]-Gingerol, a naturally occurring plant phenol that is one of the main components of fresh ginger, has a variety of pharmacological effects, including anti-oxidant, and anti-inflammatory activities (i.e., transactivation of CoX-2), and may be an effective therapeutic agent providing protection against UVB-induced skin disorders [Kim, J. K., et al., Free Radic. Res., 41(5):603-614 (2007)]. Peppermint is believed to help with loss of appetite, colds, coughs/bronchitis, sinusitis, fever, nausea and vomiting, indigestion and other digestive problems. Cardamom is reported to have antibacterial activity, including cavity-causing bacteria and bacteria that cause dandruff and acne. Stevioside, a natural plant glycoside isolated from the plant Stevia rebaudiana, has been used as a sweetener in Japan for more than 20 years and has been reported to have antihypertensive effects [Chan, P., et al., Clin. Pharmacol., 50:215-220 (2000)]. Herbs are reported to be potentially important resources for drug candidates against the onset of Alzheimer's disease [Kim, D. S., et al., J. Altern. Complement. Med., 13(3):333-340 (2007)].
There is currently a demand for low-carbohydrate, low-sugar food products. Stevia (also called sweetleaf, sweet leaf or sugarleaf) is a genus of about 150 species of herbal shrubs in the sunflower family (Asteraceae), native to subtropical and tropical South America and Central America. As a natural sweetener, stevia has a slower onset but longer taste duration than sugar (sucrose), although some of its extracts may have a bitter or liquorice-like aftertaste at high concentrations. With its extracts having up to 300 times the sweetness of sugar, stevia has shown promise as a natural sweetener especially for diabetics and others on carbohydrate-controlled diets.
Antioxidants. Among other chemical ingredients, many of the several thousand known herbs and spices have significant levels of antioxidants. The antioxidant properties of herbs and spices and their presumptive health and anti-aging effects, has led to the development and commercialization of a variety of nutritional herbal supplements, including pill forms. Although the best way to get antioxidants and other beneficial food ingredients may well be through a diversified balanced diet, this is not often the case and there is strong contemporary need for convenient health foods providing nutritional benefits. The known antioxidant activity of dietary spices (clove, cinnamon, pepper, ginger, garlic, mint, onion, etc) is one reason to suggest that, in addition to providing flavor to foods, they possess potential health benefits
Pepper. Black pepper spice is obtained from peppercorns from fruits of Piper nigrum and is used widely throughout the world. Black pepper has been traditionally used in the Indian system of medicine ‘Ayurveda’ for the treatment of many ailments. Piperine (1-peperoylpiperidine), the alkaloid that is the active ingredient of black pepper, has various properties and uses, including flavoring, insecticide activity, antidiarrhoeal activity, anti-inflammatory activity, ability to enhance the bioavailability of drugs, ability to stimulate the release of epinephrine, ability to elevate levels of circulating thyroid hormones, antioxidant functions (i.e., ability to reduce high-fat diet induced oxidative stress to cells); and analgesic, antibacterial and antiseptic properties [Vijayakumar, R. S., et al., Redox Report, 9(2)2004; Reddy, P. S., et al., 39(3): 236-238 (2001)].
Dried long pepper is obtained from Piper longum. Long pepper is of South Asian origin and has a pungent and simultaneously sweet taste. It is more pungent than black pepper. In India, a major use for long pepper is in spicy vegetable pickles. Since terpene components are missing in the aroma of long pepper, it cannot be conveniently substituted for ordinary black pepper.
Curcumin. The Indian spice Tumeric, derived from the rhizome of the plant Curcuma longa, is a gold-colored spice traditionally used in the Indian Subcontinent for health care, the preservation of food, and as a yellow dye for textiles. Curcumin (diferuloylmethane) is the ingredient of tumeric that gives this spice its yellow color. Many therapeutic functions have been attributed to tumeric, including treatment of a wide variety of diseases and conditions of the skin, pulmonary system, gastrointestinal system, aches, pains, wound, sprains, and liver disorders. Research in recent years indicated that most of these benefits of tumeric are due to cucumin. Cucumin has been shown to exhibit antioxidant, anti-inflammatory, antiviral, antibacterial, antifungal, and anticancer activities, and has potential use against various malignant diseases, diabetes, allergies, arthritis, Alzheimer's disease, and other chronic illnesses. Tumeric has been used for centuries by people of the Indian subcontinent as a component of food and as a treatment for a wide variety of ailments without any known side effects. Tumeric is called curry powder in the West. Indian and Chinese traditional medicine uses this spice as an anti-inflammatory agent to treat gas, colic, toothaches, chest pains, and menstrual problems, to help with stomach and liver problems, to heal wounds and lighten scars. Tumeric has also been used as a cosmetic. Tumeric contains various phytochemicals, including curcumin, demethoxycurcumin, bisdemethoxycurcumin, zingiberene, curcumenol, curcumol, eugenol, etrahydrocurcumin, triethylcurcumin, turmerin, turmerones, and tumeronols (Aggarwal et al, 2006).
Given the foregoing, it will be appreciated that new nutritional formulations of natural plant products are desirable to provide dietary health benefits. The present invention is directed toward this goal.
Accordingly, it is an object of the present invention to provide new and improved formulations of plant products that provide nutritional health benefits.
Another object of the present invention is to provide liquid and solid dietary nutritional supplements that contain fermented soybean, curcumin and additional herbs and spices.
Yet another object of the present invention is to provide dietary nutritional supplements that provide combinations of plant products in various forms that are convenient for human consumption.
These and other objects and advantages of the present invention and equivalents thereof, are achieved by the methods and compositions of the present invention described herein and manifest in the appended claims.